1. In-Hospital influenza vaccination to prevent cardiorespiratory events in the first 45 days after acute coronary syndrome: A prespecified analysis of the VIP-ACS trial.
- Author
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Fonseca HAR, Zimerman A, Monfardini F, Guimarães HP, Pedrosa RP, Patriota RLS, Couto Patriota TLG, Passos LCS, Dall'Orto FTC, Hoffmann Filho CR, Nascimento BR, Baldissera FA, Pereira CAC, Caramori PRA, Andrade PB, Okoshi MP, Polanczyk CA, Silveira FS, Villacorta AS, Nicolau JC, Rizzo LV, and Berwanger O
- Subjects
- Adolescent, Female, Humans, Male, Middle Aged, Hospitals, Risk Factors, Treatment Outcome, Vaccination, Adult, Randomized Controlled Trials as Topic, Pragmatic Clinical Trials as Topic, Multicenter Studies as Topic, Acute Coronary Syndrome therapy, Influenza Vaccines therapeutic use, Influenza, Human prevention & control
- Abstract
Background: Influenza vaccination prevents major cardiovascular events in individuals presenting a recent acute coronary syndrome (ACS), however the early effect of an in-hospital double-dose vaccination strategy remains uncertain., Methods: The VIP-ACS was a randomized, pragmatic, multicenter, open-label trial with a blinded-adjudication endpoint. Patients with ACS ≤ 7 days of hospitalization were randomized to an in-hospital double-dose quadrivalent inactivated influenza vaccine (double-dose) or a standard-dose influenza vaccine at 30 days post-randomization. The primary endpoint was a hierarchical composite of death, myocardial infarction, stroke, hospitalization for unstable angina, hospitalization for heart failure, urgent coronary revascularization, and hospitalization for respiratory infections, analyzed with the win ratio (WR) method in short-term follow-up (45-days after randomization)., Results: The trial enrolled 1,801 patients (≥18 years old). Median participant age was 57 years, 70 % were male. There were no significant differences between groups on the primary hierarchical endpoint: there were 5.7 % wins in the double-dose in-hospital group and 5.5 % wins in the standard-dose delayed vaccination group (WR: 1.03; 95 % CI: 0.70---1.53; P = 0.85). In a sensitivity analysis including COVID-19 infection in the hospitalizations for respiratory infections endpoint, overall results were maintained (WR: 1.03; 95 % CI 0.71---1.51; P = 0.87). Results were consistent for major cardiovascular events only (WR: 0.82; 95 % CI: 0.48---1.39; P = 0.46). No serious adverse events were observed., Conclusion: In patients with recent ACS, in-hospital double-dose influenza vaccination did not significantly reduce cardiorespiratory events at 45 days compared with standard-dose vaccination at 30 days post-randomization., Competing Interests: Declaration of competing interest H.A. Fonseca has received research grants from AstraZeneca, Pfizer, Essity, Achè, and Brazilian Ministry of Health; A. Zimerman reports research scholarships from the Lemann Foundation; M.P. Okoshi received research grants (paid to her institution) from Kiniksa, AstraZeneca, Abivax, Regeneron, Apellis, BeiGene, and Theravance, and is partially supported by CNPq, Brazil (Bolsa de Produtividade em Pesquisa, 307703/2022–3); B.R. Nascimento is partially financed CNPq (Bolsa de produtividade em pesquisa, 312382/2019–7), by the Edwards Lifesciences Foundation (Improving the Prevention and Detection of Heart Valve Disease Across the Lifespan, 2021) and by FAPEMIG (grant APQ-000627–20); J.C. Nicolau reports research grants from Amgen, Astrazeneca, Bayer, CSL Behring, Daiichi Sankyo, Dalcor, Esperion, Janssen, Novartis, NovoNordisk, Sanofi and Vifor, research support from the Brazilian Council for Scientific and Technological Development (CNPq); O. Berwanger received research grants (paid to his institution) from AstraZeneca, Pfizer, Bayer, Amgen, Servier, BMS, and Novartis. VIP-ACS trial team Ricardo Reinaldo Bergo; Gislayne Rogante Ribeiro; Hospital Santa Lucia – Poços de Caldas Carlos Eduardo da Costa Nunes Bosso; Renato Dassaev Jorge Caetano; Santa Casa de Misericórdia de Presidente Prudente – Presidente Prudente. Diego Martins de Mesquita; Instituto de Cardiologia do Distrito Federal – Brasília. Rui Fernando Ramos; Renata Mirelli de Melo Viana; Instituto Dante Pazzanese – São Paulo. João Batista de Moura Xavier de Moraes Junior; Hospital Agamenon Magalhães – Recife. Bruno Francisco de Almeida Penha; Hospital Dona Helena – Joinville. Manoel Fernandes Canesin; Hospital Universitário da Universidade Estadual de Londrina – Londrina. Luiz Eduardo Fonteles Ritt; Hospital CárdioPulmonar – Salvador. Ricardo D́Oliveira Vieira; Hospital e Clínica São Roque – Ipiaú. Magnus Gidlund; Universidade de São Paulo – São Paulo. Ricardo Pereira Silva; Universidade Federal do Ceará / Hospital Universitário Walter Cantídio. Larissa Pamela Vomeiro, Roberta Possato Fernandes, Adílio Roberto Bernardes; Academic Research Organization, Hospital Israelita Albert Einstein;, (Copyright © 2023. Published by Elsevier Ltd.)
- Published
- 2024
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